Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (April 2024)
43 slides from Lipocine's investor presentation, Apr 29, 2024
Slide 1: Corporate Presentation April 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, our strategi
Slide 3: Lipocine Pipeline
Lipocine Pipeline Development Candidate Lo. Pre-Clinical Phase 1 Phase 2 Pivotal Approved Status (Indication) LPCN 1154 Topline pivotal study (Postpartum Depression) > results 22024 P1 study completed, (Essential Tremor) submitted to FDA ae SD “ie (Obesity Management) development (Decompensated Live
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform rn as Drug + oe Carrier = faa Aqueous Intestinal Systemic Barrier Layer Wall Circulation Lip’ral based dosage form J lipid \ composition LIPOCIN= Section of Gl magnified to illustrate absorption Giliyar et al. Drug Delivery Technology, Jan 2006, Gl L
Slide 5: Oral Brexanolone for Postpartum Depression (PPD)
LPCN 1154 Oral Brexanolone for Postpartum Depression (PPD)
Slide 6: Postpartum Depression (PPD) Opportunity
Postpartum Depression (PPD) Opportunity High economic burden Critical to prevent harm to mother and infant Negative impact on family/society Suicide is a leading cause of maternal death in the first year following childbirth‘ — Up to 30% of women with PPD experience suicidal ideations? \atry Rep, 20
Slide 7: 1154 - A New Paradigm with Bioidentical NAS for PPD
LPCN 1154 - A New Paradigm with Bioidentical NAS for PPD Patients in need of a highly efficacious, fast-acting, and convenient antidepressant Synthetic NAS derivative 14-day treatment duration Long terminal half-life (20-25 hr) Robust rapid relief with 48-hour treatment duration F _ . f Up to Up to
Slide 8: 1154 Status
LPCN 1154 Status Aligned with FDA on streamlined pathway to NDA submission goal in 2024 Pilot PK Bridge Study Pivotal PK Study DA Filing Positive Topline Results Confirmatory trial to enable NDA Expected to be the first oral Established feasibility of multidose oral submission* brexanolone administr
Slide 9: 1154: Multidose Dosing Regimen Results
LPCN 1154: Multidose Dosing Regimen Results Positive results confirm 48-hour dosing regimen for the pivotal PK study Comparative Exposure Adverse Reactions of Interest 5 5 DR1 DR2 | DR3* Total Ratios (%) of geometric mean (n=12) (n=12) (n=8) | (n=32)** LPCN 1154 vs IV brexanolone Loss of consciousne
Slide 10: LPCN 2401 Obesity Management
LIPOCIN= ENHANCING HEALTH LPCN 2401 Obesity Management
Slide 11: Obesity and Overweight: A Growing Epidemic in US
Obesity and Overweight: A Growing Epidemic in US Increases the risks of heart disease, stroke, type 2 diabetes and certain types of cancer™? Target Benefits of LPCN 2401 + GLP-1 - Diabesity population (~110M adults)4 wees - ~24M obese elderly, group most vulnerable to losing muscle mass 34 ' “pone +
Slide 12: Limitations of Incretin Mimetics (GLP-1 agonists)
Limitations of Incretin Mimetics (GLP-1 agonists) Significant loss of lean mass and fat rebound potential upon cessation Plateauing of weight loss Rebound weight gain ° Weight Loss Fat Loss Lean mass Loss Body Weight Change from Baseline by Week, Observed In-Trial Data 2 3B x“ 2 Zz £ : Bs 3 i F -10}
Slide 13: 2401 Body Composition Results
LPCN 2401 Body Composition Results Significantly increased lean mass and decreased fat mass Fat Mass:Lean Fat Mass Lean Mass Android Fat Bone Mineral . . Mass Ratio (% of TM) (% of TM) (% of Fat Mass) Content () Improvement in fat:lean ratio 6 bi * Reduction of fat mass = 4 ¥ ma . te) + Increase in
Slide 14: Comparison of LPCN 2401 to T Monotherapy and Semaglutide
Comparison of LPCN 2401 to T Monotherapy and Semaglutide Differentiated impact on body composition LPCN 2401 vs T Monotherapy LPCN 2401 and Semaglutidet Android Fat ; Fat Mass Lean Mass Lean Mass (% of Fat Mass) Bone Mineral Content (% of TM) (% of TM) (kg, CBL) v n ° ® * * Placebo Adjusted CBL ° Pl
Slide 15: 2401 for Obesity Management with Improved Body Composition
LPCN 2401 for Obesity Management with Improved Body Composition Quality weight loss - preserve lean mass; quality fat loss - decreased android (visceral) fat Product Candidate Attributes Proprietary oral formulation comprising an anabolic androgen receptor agonist (ARA) and high strength a-tocophero
Slide 16: 2401 - Novel Oral Treatment for Obesity and Weight Management
LPCN 2401 - Novel Oral Treatment for Obesity and Weight Management Key takeaways* Significant body composition improvement** Decreased fat mass (FM) Increased lean mass (LM) Reduced android fat (quality fat loss) Increased bone mineral content (BMC) Potential for improved body composition in combina
Slide 17: 2203 Oral NAS for Essential Tremor
LPCN 2203 Oral NAS for Essential Tremor
Slide 18: Essential Tremor (ET)
Essential Tremor (ET) No new drug approved in 50+ years Activities affected by essential tremor of the arms and hands ¢ Tremor h igh ly d isa bl i ng an d stigmati Zi ng Essential tremor is usually most “soo Getting dressed * Stress can aggravate tremor in social setting Eating and drinking ¢ Major
Slide 19: Essential Tremor Management — Opportunity
Essential Tremor Management — Opportunity Daytime efficacy and improved tolerability remains an unmet need ee Prevalence Standard of Care Limitations Unmet Need + ~7 million patients in US" + Estimated that only ~40% of patients are diagnosed + Propranolol is the first line therapy . * 65% in need o
Slide 20: Market Potential and Competitive Development Landscape
Market Potential and Competitive Development Landscape $3B+ blockbuster opportunity as 2nd line with 20% peak adoption Products in Development* Estimated renee prevalence 2.2 % of SAGE-324: Adverse events - somnolence population? 68%, dizziness 38%, balance disorder 15%, diplopia 12%, dysarthria 12%
Slide 21: 2203: Oral GABA Positive Allosteric Modulator
LPCN 2203: Oral GABA Positive Allosteric Modulator Achieved relevant target levels with good tolerability in Phase 1 studies Typical single dose PK profiles Dose 1 = 84 doses administered across 4 single dose studies to 36 participants = No somnolence, sedation, and f Dose 3 K dizziness AE reported
Slide 22: 1148 Management of Liver Cirrhosis
LPCN 1148 Management of Liver Cirrhosis ¢ Overt Hepatic Encephalopathy (OHE) ¢ Sarcopenia
Slide 23: 1148: A Novel Approach for Management of Cirrhosis
LPCN1148: A Novel Approach for Management of Cirrhosis Key takeaways Blockbuster opportunities that addresses a significant unmet medical needs with a strong pharmacoeconomic rationale Targeted to be a “First in Class” product candidate with a novel MOA Protected by patent portfolio Expanded indicat
Slide 24: Management of Cirrhosis Market Potential
Management of Cirrhosis Market Potential Blockbuster Potential Market Size* (>$1B)
Slide 25: Unmet Needs in OHE
Unmet Needs in OHE Limited options - significant enduring medical need Key Unmet Needs Rifaximin for Reduction in Risk of OHE Recurrence Significant aigh ‘ _ ‘ 5 Mortality Recurrence Low Tolerability ¢ Rifaximin (Xifaxan™) is used to prevent episodes —_ of HE by stopping the growth of bacteria that
Slide 26: 1148: Management of Cirrhosis
LPCN 1148: Management of Cirrhosis Product Oral androgen receptor agonist Candidate Attributes Dosage form comprising testosterone dodecanoate, a unique prodrug of an endogenous hormone Targeted Mechanism of Action Stimulates muscle satellite Via improved liver health® and Induce hematopoiesis®; Imp
Slide 27: 1148 Phase 2 Results: Primary Endpoint Met
LPCN 1148 Phase 2 Results: Primary Endpoint Met A significant increase in L3-SMI L3-SMI Absolute Change from Baseline L3-SMI Change from Baseline 12 Week 12 Week 24 # é =F 10 * = 5 Sd 3.62 8 = 4 2.64 _ = 23 Q 6 * * * = 0.84 4 S2 $ % a 4 a 6 € ra 2 e-1 5 BILPCN 1148 B Placebo I ; 2 ° 0.74 3 N 14 9 15
Slide 28: 1148 Phase 2 Results
LPCN 1148 Phase 2 Results Recurrence of Overt HE was decreased with LPCN 1148 while on HE standard medication(s) LPCN 1148 switch from Placebo LPCN 1148 LPCN 1148 placebo Parameter (Through Week 24) (ultra veel: 24) (Week 20 to EOS) (Week 24 to EOS) N=14 N=15 N=11 = N=8 History of HE prior to oe 11
Slide 29: 1148 Phase 2 Results
LPCN 1148 Phase 2 Results Overall LPCN 1148 was well tolerated LPCN 1148 switch Placebo LPCN 1148 LPCN 1148 from placebo Parameter (Through Week 24) (Through Week 24) (Week 24 to EOS) (Week As to EOS) N=14 N=15 N=11 rea Total AEs 9 (64%) 9 (60%) 7 (64%) 7 (88%) Serious AEs 5 (36%) 5 (33%) 5 (45%) 1
Slide 30: 2101: Novel Potential Alternative for Women With Epilepsy (WWE)
LPCN 2101: Novel Potential Alternative for Women With Epilepsy (WWE) Endogenous Neuroactive Steroid Product Candidate Active Positive Allosteric Modulator (PAM) of the GABA, receptor Oral dosage form comprising a neuroactive steroid Product Candidate Differentiation Novel MOA specifically addressing
Slide 31: Partnering
h Partnering | qd ( dl oOhe = ww
Slide 32: 1107 Potential to be SOC in prevention of preterm birth
LPCN 1107 Potential to be SOC in prevention of preterm birth Product Candidate Oral dosage form comprising 17-hydroxyprogesterone caproate >$2B market potential Strong pharmaco-economic justification Oral, a Major Contribution to Patient Care (MC to PC), including no injection site reaction Compelli
Slide 33: 1144 Novel MOA in non-cirrhotic NASH
LPCN 1144 Novel MOA in non-cirrhotic NASH NASH Resolution with Product Candidate Highlig No Worsening of Fibrosis’ Oral dosage form comprising testosterone ester 90 No approved drug 80 p<0.001 7 Fast Track Designation 70 © Compelling P2 biopsy results in the FDA approvable endpoint Paes P< 0.05 v Sa
Slide 34: TRT Verity Alliance
TRT Verity Alliance TLANDO® and TLANDO XR TRT market is a large and growing with a significant untapped market potential — ~8M annual prescriptions in the U.S. — ~650,000 annual prescriptions in Canada Verity Transaction — $11 million license fee for Lipocine; $7.5 million received in 2024 — Up to $
Slide 35: Appendix
Slide 36: Obstetricians Awareness of PPD is High
Obstetricians Awareness of PPD is High A large majority of OB’s are comfortable making a diagnosis of PPD and prescribing an antidepressant How comfortable are you in making a diagnosis of PPD and prescribing an antidepressant? 0% wx son wx 2% 2% 1% bid —— oe ox lam very confident 1am somewhat confi
Slide 37: Obstetricians Estimate The Prevalence of PPD To Be >20%
Obstetricians Estimate The Prevalence of PPD To Be >20% Which Is Much Higher Than Previously Estimated* 45% 40% 35% 30% 25% 20% 15% 10% 5% es ne | 80-100% 60-80% of my OB patients may 40-60% 20-40% 0-20% of my OB patients may be be diagnosed with PPD of my OB patients may be of my OB patients may be
Slide 38: Presence of Sarcopenia is Linked with Worse Clinical Outcomes
Presence of Sarcopenia is Linked with Worse Clinical Outcomes Higher rates of death and hepatic encephalopathy .0g Rank, P<0.001 Odds Ratio Log Rank, P<0.001 IV, Random, 95% Cl 100 10g Rank, P<0,001 — + Log Rank, P<0.001 bal 80 - tautamine 0.07 O71 70 100 ‘iepatic be Covert HE Encephalopathy g S 404
Slide 39: 1148: Proof of Concept Study
LPCN 1148: Proof of Concept Study Study Design Endpoints * Male subjects with liver cirrhosis and sarcopenia « Primary: Change in Skeletal Muscle Index (L3 region, L3- awaiting liver transplant SMI) at Week 24 in LPCN 1148 treated participants + Two-arm (1:1 randomization, N=29) compared to placebo
Slide 40: Baseline Characteristics
Baseline Characteristics Generally well-balanced between treatment arms LPCN 1148 Placebo (N=15) (N=14) Age (years) 3.9 275 BMI (kg/m?) OQ) ae SS) L3-SMI (cm2/m?) 47.8 +7.0 MELD Score 15.9 + 3.7 Medical History 2 1 Decompensation Event* 14 (93%) 2 2 Decompensation Event 3 (87%) Hepatic Encephalopath
Slide 41: ET Patient Journey and Commonly used medications
ET Patient Journey and Commonly used medications ESSENTIAL TREMOR: COMMONLY USED MEDICATIONS : irst lin re oT propranolo DRUG PROPRANOLOL PRIMIDONE GABAPENTIN ALPRAZOLAM TOPIRAMATE NIMODIPINE First line treatment of ‘anolol [Brand Inderal ® Mysoline ® Neurontin ® Xanax ® Topamax® —Nimotop® Zonegran
Slide 42: Comparison of LPCN 2401 and T Monotherapy (Treatment A)
Comparison of LPCN 2401 and T Monotherapy (Treatment A) Differentiated impacts LPCN 2401 vs Monotl Systolic Blood Diastolic Blood Pressure Pressure HbAtc 6 0s o4 wy a : 03 9 a2 0.2 2 o4 3 ie go o 3 = o1 2 ay 3 = 02 2 3 2 & 4 03 3 3 ‘ 04 8 6 05 8 = MLPCN 2401 m TrtA Baseline N SBP. DBP. HbAtc Placebo
Slide 43: Safety Overview of LPCN 2401 Through Week
Safety Overview of LPCN 2401 Through Week 36 Well-tolerated with an overall safety profile comparable to placebo Adverse Events — Safety Set Frequency and severity of TEAEs with LPCN 2401 were Preferred Term Placebo N=19 LPCN 2401 N=19 comparable to placebo Diarrhea 2 (10.5%) 0 (0%) ; + Frequency of